Evidence Based Case Report

Sylvia Rianissa Putri

25 Juli 2017
 Case Report
Capturing an unusual or interesting disorder
Publish or perish
Valuable information
A diagnostic or therapeutic dilemma or present
important information on an adverse reaction to a
particular form of treatment.
Suggest the need for change in practice or
thinking in terms of diagnosis or prognosis.
 What is an EBCR?
systematic and evidence-based approach to
case management
describes a patient presentation in much the
same way as in a traditional case report
articulates a structured clinical question in a
format that generates key terms that can be
used to search the research evidence base
 EBCR vs Traditional CR
The search strategy is described so that the
reader can decide whether a comprehensive
search has been conducted, much in the same
way as for a systematic review
Once the relevant evidence has been
identified and appraised, it is synthesized
together with the clinicians experiential
knowledge to inform a management plan for
the patient.
 Case Report vs Case Series
Difference:
Collections of reports on the treatment of
individual patients (CS) or a report on a single
patient (CR).
Similarity:
No control groups with which to compare
outcomes, so limited statistical validity.
 How to Produce and Present an EBCR

1. Define and describe the problem

2. Search for the evidence
3. Select the best evidence only
4. Present and write up your findings under
headings
 Defining and Describing the Problem

1. Ask:
a. What is the problem?
b. How common is it?
c. Why is it important?
d. Is the problem getting worse or better?
e. Is the issue one of causation, diagnosis, benefits or
harms of care, costs, coverage?
f. What is your perspective?
2. State the question(s) clearly
3. Restate the questions in useful/searchable form
 Searching for the Evidence
Decide on the very best study design(s) that
should be employed to answer your
question(s)
Identify methods to find relevant articles
 Selecting the Best Evidence Only
1. Employ explicit and reproducible criteria for
selecting the evidence
2. Abstract the evidence from the remaining
papers into the evidence table
3. Develop criteria for communicating the
strength of the findings of articles/reports
 Presenting and Writing up Your Findings
under Headings
Introduction
(Summary of) case illustration
Structured clinical questions, PICO, literature
searching (where, results)
Discussion:
Reason for writing a CR on the particular pt chosen
What the literature search revealed
Proof for the rarity or uniqueness of a condition or
response to treatment
Scientific explanations for the position you have adopted
concerning the management of this particular case
 Presenting and Writing up Your Findings
under Headings
Describe the cause of a particular condition, why you
chose a particular clinical aspect of it and how this
influenced the outcome for the patient.
What recommendations you would make for future
patients based on your experience if your approach
differed from a standard treatment approach
What lessons can be learnt
Conclusion
References
Acknowledgements
Additional information
 Limitation of CR
The management of patients in an out-patient setting
occurs primarily in an uncontrolled environment
cannot be generalized beyond the context of the
patient reported
Results of patient responses to care are also limited by
the natural history of the disorder under study
(spontaneous remission or phases of exacerbation and
remission) if correspond with the time when care is
provided: could lead to a faulty conclusion.
Patient identity may be compromised because of the
unique qualities of a case consent to publish
CRITICAL APPRAISAL
 What is it?
Process of carefully and systematically
examining research to judge its
trustworthiness, and its value and relevance in
a particular context
 A 21st century clinician
who cannot critically read a
study is as unprepared as
one who cannot take a
blood pressure or examine
the cardiovascular system.
BMJ 2008:337:704-705
 The steps of practicing EBM
1. Ask a focused question.
2. Track down the evidence
3. Critically appraise evidence for its
validity, effect size, precision
4. apply the evidence in practice:
Practising EBM the 4 As

Step 4

Step 3

Step 2

Step 1 Apply
Appraise the
Acquire the
Ask a the best evidence
clinical evidence
evidence
question
Scenario
Mr Smith is 64 years old and recently diagnosed with atrial
fibrillation (AF), a condition associated with a high risk of
stroke. You wish to know if prescribing warfarin will reduce his
risk of stroke?

How will you answer this?

Conduct a trial?
Search and appraise a relevant RCT?
Conduct a systematic review?
Strip down to your underwear and do a ceremonial dance to
the great and mighty evidence gods
Search and appraise a relevant SR?
EBM and Systematic Review

EBM (quick & dirty) Systematic Review

Steps Steps
1. Question (PICO)? 1. Question (PICO)
2. Find the best evidence? 2. Find the best evidence x 2+
3. Appraise? 3. Appraise x 2+
4. Synthesised? 4. Synthesize
5. Apply? 5. ---

Time: 120 seconds Time: 6 months+, team

1 - 20 articles < 2,000 articles
This patient survives! This patient is dead

Find a systematic review (and appraise it quickly)!

?
Our clinical question

Population
Amongst adults with acute ACL injuries, does
Intervention
early reconstructive surgery compared with
Control
delayed reconstructive surgery lead to
Outcome 1
favourable return to former activity and/or risk of
Outcome 2
recurrent knee injury?
Practising EBM the 4 As

Step 4

Step 3

Step 2

Step 1 Apply
Appraise the
Acquire the
Ask a the best evidence
clinical evidence
evidence
question

Lecture by David Nunan

Practising EBM the 4 As

Step 4

Step 3

Step 2

Step 1 Apply
Appraise the
Acquire the
Ask a the best evidence
clinical evidence
evidence
question
 Critically Appraise the Papers
Process of reviewing a paper to identify
information of value
Not just a fault-finding exercise
 Questions to Ask When Reading a Paper

Is it of interest?
Why was it done?
How was it done?
What has it found?
What are the implications?
What else is of interest?
 Questions to Ask When Reading a Paper

Is it of interest? title, abstract

Why was it done?
How was it done?
What has it found?
What are the implications?
What else is of interest?
 Questions to Ask When Reading a Paper

Is it of interest?
Why was it done? introduction
How was it done?
What has it found?
What are the implications?
What else is of interest?
 Questions to Ask When Reading a Paper

Is it of interest?
Why was it done? introduction
How was it done? Purpose of study:
Hypothesis to be tested
What has it found? Questions to be answered
What are the implications?
What else is of interest?
 Questions to Ask When Reading a Paper

Is it of interest?
Why was it done?
How was it done? methods
What has it found?
What are the implications?
What else is of interest?
 Questions to Ask When Reading a Paper

Is it of interest?
Why was it done?
How was it done?
What has it found? results
What are the implications?
What else is of interest?
 Questions to Ask When Reading a Paper

Is it of interest? Quality of data:

Fulfill the aims of study
Why was it done? Statistical significance, not the play
How was it done?of chance
What has it found? results
Finding flaws
What are the implications?
Potential impacts of the flaws
What else is of interest?
 Questions to Ask When Reading a Paper

Is it of interest?
Why was it done?
How was it done?
What has it found?
What are the implications? abstract/discussion
What else is of interest?
 Questions to Ask When Reading a Paper

Is it of interest?
Why was it done?
How was it done?
What has it found?
What are the implications?
What else is of interest? introduction/discussion
 Standard appraisal questions
1. Are the aims clearly stated?
2. Was the sample size justified?
3. Are the measurements likely to be valid and
reliable?
4. Are the statistical methods described?
5. Did untoward events occur during the study?
6. Were the basic data adequately described?
7. Do the numbers add up?
 Standard appraisal questions
8. Was the statistical significance assessed?
9. What do the main findings mean?
10.How are null findings interpreted?
11.Are important effects overlooked?
12.How do the results compare with previous
reports?
13.What implications does the study have for
your practice?
 PRISMA (QUORUM)

Preferred Reporting Items for Systematic

Reviews and Meta-Analyses

Consists of a 27-item checklist and four

phase flow diagram
Evidence-based minimum set of items
for reporting in systematic reviews and
meta-analyses
Can be used for critical appraisal but
not designed for it

http://www.prisma-
statement.org/
Appraising a systematic review

?
Tools for critical appraisal

CASP: Critical Appraisal Skills

Programme Checklists

Critically Appraised Topics:

generic systematic reviews
(ACP Journal club)

SIGN: Scottish Intercollegiate

Guidelines Network

GATE Frame
Practising EBM the 4 As

Step 4

Step 3

Step 2

Step 1 Apply
Appraise the
Acquire
Ask a the evidence
the best
clinical evidence
evidence
question
Can I apply these results to my case?

Is my patient so different to those in the study that

the results cannot apply?
Delay or not delay?
October 27th 2014
Prof. Rodney Jackson
93
 GATE:
Graphic Appraisal Tool for Epidemiology
1991 - 2015

1 picture, 2 formulas & 3 acronyms 94

 GATE:
Graphic Appraisal Tool for Epidemiology
Graphic Architectural Tool for Epidemiology
Graphic Approach To Epidemiology

making epidemiology accessible

95
4th year medical students 1991
 Jerry Morris

numerator
epidemiology =
denominator
In: Uses of Epidemiology 1977 97
 presentation outline

GATE is a framework for:

1. study design
2. study analysis
3. study error
4. practicing EBM

1 picture, 2 formulas & 3 acronyms 99

 GATE: a framework for study design
1 picture

every epidemiological study can be hung on the GATE frame

101
1 picture, 2 formulas & 3 acronyms
 1 picture: GATE frame
cohort of British doctors

cohort / longitudinal / follow-up study

smoking status allocated by measurement (observation)

smokers non-smokers

lung cancer yes followed for 10

events counted no years

102
1 picture, 2 formulas & 3 acronyms
 1st acronym: PECOT

British doctors P Participants

randomly allocated to aspirin or placebo

Exposure E C Comparison
aspirin placebo

Outcomes yes O
MI no T Time
5 years
randomised controlled trial
1 picture, 2 formulas & 3 acronyms 103
 P
middle-aged Americans

body mass index measured

overweight E C normal weight

diabetes status
measured in all
yes
O T
participants no

cross-sectional (prevalence) study

104
 middle-aged American
women P

receive mammogram screening test

mammogram positive E C mammogram negative

yes
breast cancer O
no T

diagnostic test (prediction) study

105
middle-aged American P
women

Gold Standard

breast cancer E C no breast cancer

positive
mammogram O
test negative T

diagnostic (test accuracy) study

106
 P

smokers E C non-smokers

smoking status measured

yes cases
lung cancer O
no controls T

case-control study
(all nested in virtual cohort studies)
107
 GATE: a framework for study analysis:
1st formula: occurrence = outcomes population

the numbers in epidemiological studies can be hung on the

GATE frame
109
1 picture, 2 formulas & 3 acronyms
 1st formula: occurrence of outcomes =
number of outcomes number in population/group

British doctors P Participant Population

smoking status measured

Exposure Group EG CG Comparison Group

smokers non-smokers

Outcomes yes a b
O Time
Lung cancer no T 10 years

110
 British doctors P Population
smoking status measured

Exposure Group EG CG Comparison Group

smokers non-smokers

Outcomes yes a b
O Time
Lung cancer no T 10 years

Exposure Group Occurrence (EGO) = aEG

= number of outcomes (a) number in exposed population (EG)
111
 British doctors
P Population

randomly allocated

Exposure Group EG CG Comparison Group

aspirin placebo

Outcomes yes a b
O Time
MI no T 5 years

Comparison Group Occurrence (CGO) = bCG

= number of outcomes (b) number in comparison population (CG)
112
Epidemiology = Numerator Denominator

middle-aged American P
women
Participant Population
receive mammogram screening test

Exposure Group EG
mammogram positive D Comparison Group
mammogram negative

Time
Outcomes
breast cancer
yes

no
a
N
O
T

113
 the goal of all epidemiological studies is to
calculate EGO and CGO

P
British doctors

smoking status measured

smokers EG CG non-smokers

yes 10 years CGO:

EGO: a b
O Occurrence of
Occurrence (risk) of T
cancer in smokers no cancer in non-
Lung cancer smokers
114
 P
Middle-aged Americans

Body Mass Index (BMI) measured

High BMI EG CG Low BMI

high
O
EGO: low CGO:
Average blood Average blood
glucose in EG glucose in CG
115
 P
Middle-aged Americans

Body Mass Index (BMI) measured

High BMI E C Low BMI

high
blood glucose O T
low

cross-sectional study with numerical

measures 116
 P
Middle-aged American women
Gold Standard

Breast cancer E C no Breast cancer

positive
mammogram O
negative T
EGO: CGO:
likelihood of a positive likelihood of a positive
mammogram if breast mammogram if no
cancer breast cancer 117
 1st formula:
occurrence = outcomes population

its all about EGO and CGO

EGO CGO = Relative Risk (RR)
EGO CGO = Risk Difference (RD)

measures of occurrence: risk; rate; likelihood; probability;

average; incidence; prevalence 118
 GATE: framework for nonrandom error
2nd acronym: RAMBOMAN

Recruitment

Allocation

Maintenance
Blind
Objective
Measurements

ANalyses
120
1 picture, 2 formulas & 3 acronyms
 RAMBOMAN
Study setting

Eligible population
recruitment process
P
P

Recruitment of participants
who are the findings applicable to?
121
 RAMBOMAN: were participants well Allocated to
exposure & comparison groups?

was Allocation
to EG & CG
successful?

RCT: allocated by randomisation Cohort: allocated by

(e.g to drugs) measurement (e.g. smoking)

EG & CG E&C
EG CG EG CG measures
similar at
baseline? accurate?

O O
T T 122
 RAMBOMAN
P
were Participants well Maintained in
the groups they were allocated to?

EG CG

completeness of follow-up
compliance
O contamination
T co-interventions
123
 P
RAMBOMAN
were outcomes well Measured?

were they measured Blind to whether

participant was in EG or CG ?
EG CG

O
T
124
 P RAMBOMAN
were outcomes well Measured?

were they measured Objectively?

EG CG

O
T
125
 P RAMBOM AN
were the ANalyses done well?
EGA CGA
If RCT were Intention To Treat (ITT)
EGC CGC analyses done?

a b
O
T 126
 RAMBOMAN
P
were the ANalyses done well?

EG CG adjustment for baseline

differences/confounding?

O
T
127
 GATE: random error: 2nd formula:
random error = 95% confidence interval
sample from a
population

EGO 95% CI CGO 95% CI

There is about a 95% chance that the true value in the underlying
population lies within the 95% CI (assuming no non-random error)
128
1 picture, 2 formulas & 3 acronyms
 GATE: a framework for error in
systematic reviews & meta-analyses:
3rd acronym: FAITH

129
1 picture, 2 formulas & 3 acronyms
systematic review: a study of studies
study sources

studies screened

studies appraised & allocated:

included excluded

studies summarised
& pooled if
homogeneous 130
 critical appraisal of SR: FAITH
study sources
Find
studies screened
Appraise
studies appraised & allocated:
Include
included excluded

Total studies summarised

& pooled if
Heterogeneity? homogeneous 131
1 picture, 2 formulas & 3 acronyms
GATE: framework for the 4 steps of
EBP

133
 the steps of EBP:
1. Ask
2. Acquire
3. Appraise
4. Apply & Act

134
 EBP Step 1: ASK - turn your question
into a focused 5-part PECOT question

P
1. Participants

2. Exposure 3. Comparison
E C

4. Outcomes yes
O 5. Time
no T
135
EBP Step 2: ACQUIRE the evidence use
PECOT to help choose search terms

P
Participants

Exposure E C Comparison

Outcomes yes
O Time
no T
136
 EBP Step 3: APPRAISE the evidence
with the picture, acronyms & formulas
P P Recruitment
Allocation
E
Maintenance
C E C
blind
O objective
O
Measurements
T
T ANalyses
Occurrence = outcomes population
Random error = 95% Confidence Interval 137
APPLY the evidence by AMALGAMATING the
relevant information & making an evidence-
based decision: the X-factor

138
139
X-factor: making evidence-based decisions

epidemiological
evidence economic
person
family values & system legal
community
preferences features
political
practitioner patients
clinical
circumstances

X
Practitioner e pertise: putting it all together - the art of practice
Clinical expertise in the era of evidence-based medicine and patient choice. EBM 2002;736-8 (March/April)
140
GATE critically appraised topic
(CATs) forms
GATE CAT 4-sheet workbook (in Excel)
sheet 1: GATE-Ask & Acquire

142
GATE CAT 3-sheet workbook (in Excel)
sheet 2: GATE-Appraise (with calculator)

143
GATE CAT 3-sheet workbook (in Excel)
sheet 3: GATE-Apply

144
 Further References
The pocket guide to critical appraisal
Kajian kritis makalah ilmiah kedokteran klinik
menurut kedokteran berbasis bukti (KBB)
What is critical appraisal?
The GATE frame: critical appraisal with
pictures
Thank you